Delivery preparation and facilitation device and preparatory gymnastics

ABSTRACT

The present invention pertains to a device for preparing a pregnant woman to delivery and facilitating the delivery itself. Said device comprises an entirely expandable stretch body, which is positioned in the expulsion area of the urogenital canal in such a way that it is partly inside the vagina and partly outside. The invention also relates to preparatory gymnastics method involving the inventive device.

[0001] The present invention relates to a device for helping a pregnantwomen to prepare for giving birth and to make giving birth easier whichhas an expandable elongated body which is positionable in the region ofthe vaginal orifice such that it is located partly inside the vagina andpartly outside of the vagina. The invention further relates to anexercise method involving the use of such a device for preparing to givebirth.

[0002] In Germany, there are approximately 850,000 births per year.According to the most recent available perinatal statistics of 1995, therate of episiotomy, among both first time and subsequent births, was atotal of 58.9% (less the rate of cesarean section of 17.4%). This meansthat approximately 500,650 epiosotomies are carried out yearly inGermany (Commission for Perinatalogy and Neonatalogy, BPE Annual Report1995). In about 20% of all births a tear in the perineum occurs as aresult of which the risk of death due to complications is furtherincreased. In spite of numerous traditional and modem methods forpreparing and for facilitating giving birth (e.g. Leboyer, Read, Odent),the mentioned statistics remain unchanged in relation to one anotherafter decades. Even the new age pregnancy exercices to prepare forgiving birth and the pregnancy consultation of midwives have onlyimproved these figures unsubstantially.

[0003] The episiotomy, first described by Ould in 1742, still conjuresup a horrible image even after 250 years. Although, it was proposed andcarried out as a relief for women and to accelerate delivery, it isstill feared by many women to this day due to its painfulness, and it ishated for its negative consequences. Avoidance of the episiotomy hastherefore been a long felt need in the field along with the goal to makethe delivery easier for mothers with less fear involved.

[0004] An additional problem of modem birthing assistance is theincreasing disproportion between the fetal/infant head and the femalepelvis. The cranial circumference of newborns is steadily increasingsuch that the measurement program established by Hausmann for thestandard size of the biparietal diameter using ultrasound must becontinuously upwardly corrected. The cause for this might be seen, onthe one hand, to be the result of increasing exposure of pregnant womento light, noise, and other stimulation (for example neon lights, electrosmog, car noise, etc . . . ), and on the other hand, due to the natural,modem androgenous type of woman (tall, narrow female pelvis and narrowhips) which naturally makes giving birth more difficult.

[0005] It is known for treating sedimentation of the blood andincontinence problems in women to insert an inflatable balloon deep intothe vagina in order to provide, in the inflated state, a mechanicalblockage of the bladder while raising the uterus. For example, EuropeanPatent publication EP 0,663,197 A1 describes a support body which keepsits shape and is made of elastic rubber material with areas of differentwall thickness which expands conically from a base region in thedirection of a top surface at the opposite end of the support body in aconical manner, a piece of hose being sealingly connected to the baseregion. The top surface is reinforced in a ring-shape and has a softconcavely formed inner region. The support body is inserted into thevagina with the base downward and is left in place for hours to supportthe vaginal wall.

[0006] U.S. Pat. No. 3,626.949 describes a cervical dilator which hasnot however achieved any significant success in practice. It discloses aPVC envelope or case having a hose connection for filling up the casewith a fluid under pressure. The case can be inserted into the cervicalcanal while folded up and is then periodically expanded under pressuresuch that the case expands radially against the cervical wall to therebysimulate contractions. Between opposed ends of the case there is a waistportion which is not expandable in a radial direction, which waistportion is positioned inside the edge of the cervix in order to preventthat the expanded waist portion moves in an axial direction underpressure.

[0007] A further cervical dilator is described in U.S. Pat. No.3,480,017. This dilator uses an inflatable case which is inflatable to asubstantially disk-shaped body, which is positioned in use inside theuterus and inflatable using an inflation tube whose opening is insidethe case. The case comprises a circumferential constriction such that agroove is formed in the cylindrical exterior wall of the case wheninflated into a disk. The cervix supported by the groove can be expandedin this way in order to induce birth. The application of the knowndevice is only possible by a doctor who has acquired the skills tomanipulate the shell against the cervix using the inflating tube as ahandle, without damaging the amniotic sack or the fetus' head. As aresult of its flat disk shape,. the known cervical dilator isparticularly suited only for this application.

[0008] In French Patent publication FR-592,104, there is described adilator to be inserted in the perineum which is made of an elongatedelastic material balloon which can be laterally expanded by inflationwhile having its lengthwise expansion limited. By methodical use andprogressive expansion, tissue having undergone such exercise will yieldwhile giving birth without tearing.

[0009] This prior art balloon can also be actuated intermittently usinga three-way valve. During use, it is important to pay attention that theballoon is only inserted into the vagina to the extend that the middlesection of the balloon rests in the area of the perineum. Duringinflation, the balloon should form inside the perineum a ring-shapedconstriction by means of which the balloon is secured in the axialdirection.

[0010] In the embodiment of this prior art in which the balloon has acentral inflation tube, there is the danger that the inner end of thetube is pushed during insertion too close to the cervix where seriousinjury is possible (causing bleeding or breakage of the amniotic sack).

[0011] In the case of the embodiment in which the balloon is providedwith non-stretchable inner strips for preventing a lengthwise extensionof the balloon, there is the danger that the balloon will be suddenlycatapulted inwardly towards the cervix during inflation once apredetermined level of inflation is reached, which can lead to theabove-mentioned serious injuries.

[0012] The known device should therefore only be used under thesupervision of a physician, in particular because it is practicallyimpossible for a pregnant woman, due to the corresponding size of herabdomen, to locate the correct axial position of the balloon.

[0013] Accordingly, it is the object of the present invention toconstruct the above-mentioned device such that its application for apregnant women is pleasant and safe, and can be carried out easily byherself; and, finally such that its use should substantially contributeto the significant reduction of perineum tearing or episiotomiesoccuring during birth. Associated therewith, an undesired drop in thepelvic floor, and later occurrences of bladder incontinence and sexualdisturbance as a result of physiological and psychosomatic complicationsoccurring postpartum can be prevented.

[0014] This object is provided by a device having the characteristics ofclaim 1 as well as a method having the characteristics of claim 13.

[0015] The device according to the invention comprises an expandableelongated shaped body which is positionable in the region of the vaginalorifice such that it is located partway inside the vagina and partwayoutside the vagina. By the expansion of the elongated body, the vaginacan be substantially expanded and the birth canal as well as the vaginalorifice can be expanded in advance to facilitate giving birth. With thistraining and stretching effect, eposiotomies as well as an undesirabledrop in the pelvic floor can be avoided to a large extent along withcomplications associated therewith. The expandable body maintains itsdistance from the cervix which it should never contact in order avoidirritations.

[0016] By shaping the expandable elongated body such that the shapefacilitates its positioning in the area of the vaginal orifice, thedevice is self-centering in the region of the vaginal orifice andself-anchoring. This can be achieved for example by shaping the body asa FIG. 8 in its lengthwise axis. It is essential that the expandablebody is expandable in its entirety (i.e. the whole shape expands), sincespecifically the expansion in the area of the vaginal orifice is to beexercised.

[0017] In accordance with a preferred embodiment, it is provided thatthe body is expandable by means of a variable fluid filling system. Thefluid can be for example a gel or an aqueous liquid which may betemperature controlled if need be, or the fluid may be a gas such asair. In particular cases, air pressure provided by blowing with themouth may be used. Also preferably, the body may be formed as a balloonhaving a filling tube connected to an end which during use is orientedexternally. Latex or a silicone product are examples of skin compatiblematerials which may be used.

[0018] According to a preferred embodiment, the balloon is assembledfrom two parts or half-shells which are connected together along acircurmferential seam. The circumferential seam is preferably positionedin the area of the waist portion. The half of the device positionedoutside of the vagina has a greater wall strength than the halfpositioned inside. In this way, it is provided that the balloon isself-stabilized under high pressure and leads to a minimal rise inpressure for vaginal dilation.

[0019] In a further preferred embodiment, the device comprises an airpump with a manometer or pressure gauge connected to the filling hose ofthe balloon. The pump which may comprise a hand-pump can be used to pumpup the expandable body in steps or stages up to a maximum pressure whichmay be about 160 mm Hg, measured using the pressure gauge.

[0020] The pressure gauge preferably comprises an air-release screwwhich is used to release the pressure at the end of the therapy or forrelief during use.

[0021] Finally, it is important to make sure that the maximum expansionof the balloon transversely to the lengthwise axis measures 9 to 10 cm,preferably 9.4 to 9.6 cm. This corresponds approximately to the averagediameter of a newborn head with a cranial circumference of approximately35 cm at birth.

[0022] A further embodiment provides that a safety valve be arranged onthe pressure gauge in order to limit the maximum pressure. The pressuremay be limited, for example, to 200 mm Hg. The safety valve opens whenthe pressure limit is exceeded.

[0023] According to another preferred embodiment, the balloon assembledfrom two-half shells is constructed such that the half shelves form twogas-tight chambers separated from one another. In this way, they can beeach indepentently filled or deflated such that the balloon can beadjusted to the individual needs of the patient. The hose for inflatingand deflating the half-shell positioned inside the vagina is provided topass through the other half-shell. Both hoses exit at the end of theballoon directed outwardly. The device is particulary advantageous forpatients who have already given birth and who have during the previousbirth endured tearing of the perineum leading to painful scarring. Forthis purpose, the device can be pumped up altematingly in pressure stepsof 10 mm Hg in order to exert pressure on alternating sides of thevaginal orifice.

[0024] In a further preferred embodiment, the half shell positioned inthe vagina is fillable by means of a separate inflation hose. Theseparate filling hose can either pass outside of the deivce or throughthe inside of the half-shell positioned outside of the vagina such thatboth tubes extend outwardly from the birth canal. Furthermore, accordingto a variant embodiment, the two hoses extend concentrically one insidethe other.

[0025] Finally, it preferred that the device comprises a three-way valvefor selecting the filling mode of the two half-shells. The two separatedfillable half-shells can be filled together or individually inflated.The filling pressure is monitored for each corresponding filling modeusing the pressure gauge. Also, the order for deflation can be selectedusing the three-way valve. When using concentrically extending hoses, acorresponding constructively built three-way valve can be provided.

[0026] In addition to the above-mentioned device, the invention furtherrelates to a method for preparing to give birth using exercises in whichthe device according to the invention is used such that the expandablebody is positioned partly outside and partly inside the vaginal orifice,and thereafter is expanded to a desired size and finally maintained inan expanded state for a predetermined time in its position. Preferably,the expansion of the device is increased with each repeated use in orderto achieve an increasing preparatory expansion of the birth canal. Themethod carried out as a stretching or expansion exercise should becarried out several times per day as of the thirty-sixth week ofpregnancy. Additionally, it is preferable that the expanded body beremoved carefully in a direction of the vaginal orifice after apredetermined time period. The time period that the device should remainin the birth canal is between 10 to 20 minutes, preferably 15 minutes,in accordance with the subjective feeling of the patient: too muchstretching tension indicates too high a pressure in the balloon. Reliefis achieved by the step-wise actuation of the air pressure releasescrew.

[0027] The numerous advantages of the mentioned method are: an easierdelivery resulting from prior stretching or expansion of the birth canaland the outer vaginal orifice; a faster delivery, in particular in thecase of first time mothers; better oxygen supply to the child as aresult of minimal pressure on the fetal cranium as it emerges; areduction of labor-inducing medication, in particular in the case offirst time mothers; a reduction in the pain of childbirth and minimalcramping caused by stretchable musculature; a clear reduction in the useof pain killers and local anesthesia; less risk of allergic shock due tolocal anesthesia; a reduction in the use of peridural and epiduralanesthesia (spinal cord anesthesic); a significant reduction in the needto resort an episiotomy which is always painful for the mother (andtherefore feared by her) and the inevitable stitches following theepisiotomy; as well as a quicker recovery of the vaginal musculature bysparing the musculus bulbo cavernosus, musculus bulbo spongiosus and themusculus sphincter ani since the incidence of macro and micro muscletearing is reduced.

[0028] Further advantages resulting from a problem-free delivery arebetter care of the child by the mother, who can be more active and agilein the absence of an episiotomy, such that she can care for the childherself without feeling sick and injured. As a result of the reductionof pain achieved according to the invention, the production ofprolactine is increased whereby lactation (breast feeding) is improved.It is furthermore important that the physiology, function and appearanceof the vagina and vulva are maintained to a large extent, and therebythe mother's sex life after giving birth is not affected. A shorterrecovery time in hospital and the possibility of home birth may alsocontribute to relief of medical insurance plans.

[0029] The invention will be better understood by way of the followingdetail description of a preferred embodiment with reference to theappended drawings in which:

[0030]FIG. 1 illustrates a preferred embodiment of the device accordingto the invention in use in the deflated state;

[0031]FIG. 2 illustrates the embodiment as shown in FIG. 1 in which thedevice is in the expanded state;

[0032]FIG. 3 illustrates a cross-section of the embodiment of the deviceaccording to FIGS. 1 and 2; and

[0033]FIG. 4 shows a cross-section of a further embodiment of a deviceaccording to the present invention.

[0034]FIGS. 1 through 3 illustrate a balloon 1 for pneumatic dilation ofthe birth canal which is inserted into the vagina 2 towards the cervix 7of uterus 10. The oval and FIG. 8 shaped expandable balloon 1 having amiddle neck or waist portion 15 comprises, in its half 14 positionedexterior of the vagina 2, a greater wall strength than the half 13positioned inside. The waist portion 15 of the balloon 1 itself isreinforced. The balloon 1 when deflated and folded up is inserted intothe vagina 2 with lubricating gel such that approximately three to fourcentimeters of the balloon 1 can be seen in front of vulva 3. This isimportant since the outermost portion of the vagina 2 in particular, andabove all, the vaginal orifice 4 should be expanded. This is the mostsensitive part of the female birth canal and due to the danger of a tearof the perineum, it is at the same the most endagered anatomical part.The balloon 1 is now carefully pumped up using hand-pump 5 in steps of20 mm Hg up to a maximum pressure of 160 mm Hg, which is monitored usingmanometer or pressure gauge 6. The stretching feeling subjectivelyexperienced by the pregnant woman sets the limit for inflation. Afterapproximately 15 to 20 minutes, the device 1 is carefully and gentlypulled out in the direction of the vagina so that the patientexperiences a “feeling of giving birth” and this sensation can bedeepened in subsequent exercises which leads to a considerabletranquilizing effect. This exercise is repeated several times per daysuch that the patient expands the vaginal orifice continuously andcompletely painlessly. It is important that the desired diameter of theballoon is measured by corresponding pumping (i.e. by counting the pumpstrokes) outside of the vagina. The pressure on the pressure gaugeshould never exceed 200 mm Hg. The scale of the pressure gauge iscorrespondingly marked.

[0035] The maximum diameter of the waist portion should be 9.5 cm sincethe biparietal diameter of fetal cranium at birth is on average of thissize, which corresponds to a cranial circumference of 35 cm. If anultrasound examination carried out by the medical doctor determines thatthe child is particularly larger, the diameter of the expansion can besimply increased accordingly. However, the patient should still controlthe size of the balloon to suit her subjective feeling.

[0036] As a basis of measurement for the required birth dilationpressures, the following test results can be used:

[0037] According to scientific studies by R CALDEIRO-BARCIA theintraamnial pressure can rise under normal contraction activiy up to 100mm Hg. The systolic blood pressure of the mother (normally 120 mm Hg)can rise briefly during contractions during the period of expulsion upto between 180 to over 200 mm Hg. The pressure of the uterus musculaturereaches, towards the end of the expansion during delivery, a pressure ofup to 200 mm Hg against the surrounding vaginal tissue. According to C.LINDGREN, the maximum pressure on the fetal cranium in the area of theperineum 8 can reach a peak value up to 300 mm Hg during contractionsshortly before birth. In order to keep the artificial dilation describedherein within the physiological range, a limit of 200 mm Hg isrecommended. Basically, the dilation should not be carried out beforethe 36th week of pregnancy.

[0038] The demonstration and explanation of the method for dilating thebirth canal should basically be carried out with the patient by thephysician in charge or by the midwife. It is recommended to carry outthe first dilation under continuous CTG control (cardiotopography=continuous recordal of fetal heart sounds and contractions)by the physician in charge or the midwife.

[0039] Cleaning of the device after use can be done with soap and waterand air dried. Disinfecting using commercially available disinfectantsis recommended.

[0040]FIG. 3 shows further the hose connection 16 as well as theexpandable balloon 1 in its expanded state 17. The two parts orhalfshells 13, 14 are glued or joined together overlapping about acircumferential seam which coincides with the waist portion 15. Theoverlapping region is shown in dashed lines.

[0041]FIG. 4 shows a cross-section according to a further embodimentaccording to the present invention. The parts or half-shells 21, 22 andthe balloon 20 are shown. In the area of the waist portion 23, amembrane 24 is arranged inside the balloon which membrane comprises anopening 25 which is connected to a first hose 26. The outer half-shell22 is connected by means of a wall orifice 27 to a further connectinghose 28. The two connecting hoses 26, 28 are connected to a three-wayvalve 29 which in turn is connected by a hose 30 to a pressure gauge 21and hand-pump 22. An air-release screw 33 is also provided betweenpressure gauge 31 and hand-pump 32 as well as an elastic seam 34 wherethe first connectiong hose 26 passes through the wall of the outer halfshell 22.

[0042] In the embodiment according to FIG. 4, three configurations canbe selected using three-way valve 29. In the first configuration, aconnection is established between hose 30 and both connecting hoses 26,28. In this way, both chambers, i.e. both parts or half shells 21, 22are simultaneously inflated or deflated. In the next configuration, aconnection between hose 30 and connector hose 26 is established for theinner half-shell 21, whereby the connection to the second connector hose28 is interrupted. In a third configuration, a connection is establishedbetween hose 30 and connector hose 28 to the outer half-shell 22 wherebythe connection to the other connector hose 26 is interrupted. In thisway, the outer half shell 22 can be inflated using the hand-pump 32 ordeflated by means of the air-release screw 33. The connector hose 26 tothe inner half shell 21 extends through the outer half-shell 22 directlyto the membrane 24 where hose 26 connects to the opening 25 in membrane24. As a result of such a twin-chamber construction, the volume ofballoon 20 can be individually adjusted to the needs of the user. Thepressure of each individually controlled balloon chambers can beseparately monitored using pressure gauge 31.

1. Device for preparing to give birth and making delivery easier for apregnant woman, the device having an expandable elongated body which ispositionable in the area of the vaginal orifice such that it is locatedpartly inside the vagina and partly outside the vagina, characterized inthat, the body is constructed to be expandable in its entirety whereinit comprises a waist portion (15;23) expandable along with the body, thewaist portion being self-centering in the area of the vaginal orifice(4) during use.
 2. Device according to claim 1, characterized in thatthe body is expandable by means of a variable air or fluid inflation. 3.Device according to claim 2, characterized in that the body is formed asa balloon (1;20) having at least one inflation hose (12;28) on its enddirected during use outwardly.
 4. Device according to claim 3,characterized in that the balloon (1;20) is an assembly of twohalf-shells (13, 14; 21, 22) connected together along a circumferentialseam (15;23).
 5. Device according to claim 4, characterized in that thecircumferential seam is arranged in the area of the waist region(15;23).
 6. Device according to claim 4, characterized in that the wallstrength of the outer half-shell is larger during use than the innerhalf-shell.
 7. Device according to claim 3, characterized in that thedevice includes an air-pump (5;32) with an air-pressure gauge (6;31)connected to the inflation hose (12;30) of the balloon.
 8. Deviceaccording to claim 7, characterized in that an air-release screw (33) isprovided between the air-pump (5;32) and the air pressure gauge (6;31),the pressure in the balloon (1;20) being adjustable by means of the airrelease screw.
 9. Device according to claim 7, characterized in that asafety valve is provided to limit the maximum pressure.
 10. Deviceaccording to claim 4, characterized in that the half-shells (21, 22)form two air tight chambers separated from one another.
 11. Deviceaccording to claim 10, characterized in that the half-shell (21)positioned in the vagina is inflatable by means of a separate inflationhose
 26. 12. Device according to claim 10, characterized in that thedevice comprises a three-way valve (29) for selecting the inflation modeof the two half-shells (21, 22).
 13. An exercice method for preparing togive birth using a device according to claim 1, characterized in that,the expandable body is positioned partly outside and partly inside thevaginal orifice (4), thereafter the expandable body is expanded to adesired dimension and finally in the expanded state maintained apredetermined time in its position.
 14. Method according to claim 14(sic), characterized in that the expansion of the expandable body isincreased with repeated use in order to achieve an increasingpreparatory stretching of the birth canal.
 15. Method according to claim15 (sic),characterized in that the expandable body is pulled from thevagina (2) after a period of time.
 16. Method according to claim 16(sic), characterized in that the time period is between 10 to 20minutes, preferably 15 minutes.
 17. Method according to claim 15,characterized in that the expansion of the waist region is selected tobe up to a diameter of 10 cm.